BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED AIRE

    MDR report key: 15001780 · Received July 13, 2022

    Report

    Report Number
    2438477-2022-00067
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 11, 2022
    Report Date
    July 12, 2022
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    UDI-DI
    00822383111605
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS CONTACTED BY A DISTRIBUTOR REGARDING A REPORTED INJURY INVOLVING A BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER STATED THAT THE SYSTEM'S PUMP WAS DEFECTIVE BECAUSE IT "WON'T ALLOW HIM TO LOCK, CHANGE WEIGHT OR INFLATE." HE REPORTED HAVING DEVELOPED PRESSURE ULCERS AS A RESULT AND RECEIVING MEDICAL TREATMENT FOR THEM. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773277 MED AIRE BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM FNM EEZCARE MEDICAL CORP. 14030 00822383111605

    Patients

    Seq Age Sex Outcome Treatment
    1 Male